Medical Editor: John P. Cunha, DO, FACOEP
Aciphex Sprinkle (rabeprazole sodium delayed-release capsules), for oral use, is a proton-pump inhibitor (PPI) indicated for the treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age. Common side effects of Aciphex Sprinkle include:
- abdominal pain,
- sore throat,
- dry mouth,
- swelling of extremities,
- increased liver enzymes,
- hepatitis, and
- muscle and joint pain.
The recommended dosage of Aciphex Sprinkle in pediatric patients 1 to 11 years of age for up to 12 weeks is based on the child's body weight. Less than 15 kg: 5 mg once daily with the option to increase to 10 mg once daily, if inadequate response; 15 kg or more: 10 mg once daily. Aciphex Sprinkle may interact with antiretrovirals, warfarin, methotrexate, digoxin, and drugs dependent on gastric pH for absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Tell your doctor all medications and supplements your child uses. Tell your doctor if you are pregnant or plan to become pregnant before using Aciphex Sprinkle; it is unknown if it would affect a fetus. It is unknown if Aciphex Sprinkle passes into breast milk. Consult your doctor before breastfeeding.
Our Aciphex Sprinkle (rabeprazole sodium delayed-release capsules), for oral use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Bone Fracture [see WARNINGS AND PRECAUTIONS]
- Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
- Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
- Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
- Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The efficacy of ACIPHEX Sprinkle was established in a two-part, randomized, multicenter, double-blind, parallel-group study of 127 pediatric patients 1 to 11 years of age with a history of at least one GERD symptom within the 3 months before screening and a positive esophagogastroduodenoscopy (EGD; Hetzel-Dent Endoscopic Classification System, Grade ≥1 and Histological Features of Reflux Esophagitis Scale, Grade >0). The two-part study consisted of a 12-week treatment period in patients with endoscopically-proven GERD followed by a 24week, double-blinded extension study. Subjects had a mean age of 6 years (range: 1 to 11 years) and 44% (56/127) were female and 56% (71/127) were male. Of the 127 subjects enrolled, 78% (99/127) were white, 10% (13/127) were black, and 2% (3/127) were Asian.
In the study, patients less than 15 kg body weight received either 5 mg or 10 mg ACIPHEX Sprinkle and patients 15 kg or greater body weight received 10 mg ACIPHEX Sprinkle. In this study, some patients were treated for 36 weeks. The most common adverse reactions leading to discontinuation were vomiting, abdominal pain, diarrhea, and nausea. The most common adverse reactions from the first 12 weeks of treatment are listed in Table 1.
Table 1: Common Adverse Reactions* in Pediatric Study
(Ages 1 To 11 Years First 12 Weeks of Treatment)
|Adverse Reaction||Patients Less than 15 kg||Patients 15 kg or greater|
|* incidence of adverse reactions ≥9%|
The safety profile was similar for those patients who received treatment for up to 36 weeks.
Adults And Adolescents Experience With Other Rabeprazole Formulations
The data described below reflect exposure to rabeprazole sodium delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo-and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female. The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other. Most patients received either 10 mg, 20 mg, or 40 mg per day of rabeprazole.
An analysis of adverse reactions appearing in ≥2% of rabeprazole-treated patients (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs. 1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs. 1%), and constipation (2% vs. 1%).
Other adverse reactions seen in controlled clinical trials, which do not meet the above criteria (≥2% of rabeprazole-treated patients and greater than placebo) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.
In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to rabeprazole that occurred in ≥2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%). The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in this study that were not previously observed in adults.
The following adverse reactions have been identified during post approval use of rabeprazole sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia
Ear and Labyrinth Disorders: vertigo
Eye Disorders: blurred vision
Gastrointestinal Disorders: fundic gland polyps
General Disorders and Administration Site Conditions: sudden death
Hepatobiliary Disorders: jaundice
Immune System Disorders: anaphylaxis, angioedema, systemic lupus erythematosus, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
Infections and Infestations: Clostridium difficile-associated diarrhea
Investigations: Increases in prothrombin time/INR (in patients treated with concomitant warfarin), TSH elevations
Metabolism and Nutrition Disorders: hyperammonemia, hypomagnesemia
Musculoskeletal System Disorders: bone fracture, rhabdomyolysis
Nervous System Disorders: coma
Psychiatric Disorders: delirium, disorientation
Renal and Urinary Disorders: interstitial nephritis
Respiratory, Thoracic and Mediastinal Disorders: interstitial pneumonia
Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions, including bullous and other drug eruptions of the skin; cutaneous lupus erythematosus, erythema multiforme
Read the entire FDA prescribing information for Aciphex Sprinkle (rabeprazole sodium)